NCT04100772

Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above

A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety and Immunogencity of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） in Healthy People Aged 6 Weeks and Above

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 6 Weeks
• Healthy volunteers: Accepted

Summary

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.

Conditions

• Pneumococcal Infections
• Streptococcal Infections
• Bacterial Infections

Interventions

Type	Name	Description
BIOLOGICAL	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）	0.5mL,Intramuscular other name:PCV13i
BIOLOGICAL	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	0.5mL,Intramuscular other name:Prevnar

Timeline

• Start date: 2020-05-18
• Primary completion: 2021-06-23
• Completion: 2022-08-23
• First posted: 2019-09-24
• Last updated: 2022-10-31

Locations

1 site across 1 country: China